Mayo Clinic Laboratories > BioPharma Diagnostics > FAQs > Research collaborations

Research Collaborations

FREQUENTLY ASKED QUESTIONS

Find out about setting up a contract with Mayo Clinic, analytical validation, the role of the Mayo Clinic Institutional Review Board, and how your data will be handled.

Research Collaborations FAQ

Contracting Contracting
Analytical validation Analytical validation
Institutional Review Board (IRB) Institutional Review Board (IRB)
Data and monitoring Data and monitoring

Contracting

Can a collaboration agreement and lab services agreement be combined?

Not at this time. Each service offering has its own needs in terms of intellectual property. Therefore, each service offering has its own agreement template.

What is the process for setting up a contract with Mayo Clinic?

The following process occurs after a budget is approved:

  1. BioPharma Diagnostics sends a master collaboration agreement (MCA) template to you for review.
  2. The MCA contains a statement of work (SOW) template that must be negotiated.
  3. The MCA is fully executed.
  4. A project-specific SOW is drafted by BioPharma Diagnostics and sent to you for review.
  5. Upon execution of the project-specific SOW, project activities (including institutional review board submission) can begin.

How long will it take to set up my project?

Project setup is typically completed in two to six months based on the complexity of the project. The following steps are required for setting up a project. The time frames in business days are estimated and can vary. Additionally, individual line items overlap in most cases.

1. Pre-contract: feasibility and budget

  • Inquiry received and data gathered (5 days)
  • Non-disclosure agreement executed, if applicable (14 days)
  • Feasibility confirmed and Mayo team identified (14 days)
  • Project logistics and budget estimates gathered (14 days)
  • Bid negotiated and approved (5 days)

2. Contract

  • Contract created and negotiated (up to 5 business days for draft contract; 2 to 4 weeks for each round of redline responses)

3. Post-contract: creation of internal operations

  • Project handed off to execution team (up to 10 days from contract execution)
  • Project setup and implementation completed (1 to 4 weeks)
  • IRB review and approval complete (4 to 6 weeks from time of submission)
  • Project details finalized and project opened for activity (1 to 4 weeks)

4. Project execution: project started

Analytical Validation

Can instruments be brought into the Mayo labs for my project?

Analytical validation is discussed during the project's feasibility assessment. With institutional approvals, your instruments can be brought into the lab for the project activities.

INSTITUTIONAL REVIEW BOARD (IRB)

Is the BioPharma Diagnostics staff required to have human subjects protection training?

All research staff members are required to take the Mayo Clinic Human Research Protection Program exam before participating in research activities.

Is the Mayo Clinic IRB fully accredited?

The Mayo Clinic IRB is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

Can an external IRB be used?

No. Projects that require review must be submitted to the Mayo Clinic IRB.

How often does the Mayo IRB meet for projects that require full board review?

The Mayo Clinic IRB meets at least three times per week. A fourth meeting is held every other week.

What is the turnaround time for IRB review?

Turnaround time for IRB approval is four to six weeks from the date of submission. Timing can vary based on the complexity of the project.

Data and Monitoring

How will project data be provided or transferred to me?

BioPharma Diagnostics will send data to you through your electronic data capture (EDC) system or through an Excel spreadsheet, unless otherwise determined by the project team.

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